Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy (BIBC)
This study is currently recruiting participants.
Verified July 2012 by Xijing Hospital
Sponsor:
LiNanlin,Ph.D, Chief Physician,Clinical Professor
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01652560
First received: July 21, 2012
Last updated: July 25, 2012
Last verified: July 2012
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Purpose
- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer Bevacizumab Neoadjuvant Chemotherapy Molecular Targeted Therapy |
Drug: bevacizumab |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Bevacizumab
U.S. FDA Resources
Further study details as provided by Xijing Hospital:
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: From enrollment to disease progression ] [ Designated as safety issue: No ]From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Secondary Outcome Measures:
- overall response [ Time Frame: From enrollment to disease progression ] [ Designated as safety issue: No ]From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| bevacizumab combined neoadjuvant chemotherapy |
Drug: bevacizumab
The patients will be treated with Avastin combined neoadjuvant chemotherapy
Other Name: Avastin
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Criteria
Inclusion Criteria:
- HER2-negative breast cancer patients
- Without surgery
- Plans to neoadjuvant chemotherapy
Exclusion Criteria:
- HER2-positive breast cancer patients
- Post-operative patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652560
Contacts
| Contact: Nanlin Li, Phd | +86-186-2963-7041 | nanlin-74@163.com |
| Contact: Hongyu Xiao, Master | +86-186-2963-7040 | louch2008@116.com |
Locations
| China, Shaanxi | |
| Xijing Hospital ， Fourth Military Medical University | Recruiting |
| Xi`an, Shaanxi, China, 710032 | |
| Contact: Nanlin Li, Ph.D +86-186-2963-7041 nanlin-74@163.com | |
| Contact: Hongyu Xiao, Master +86-186-2963-7040 louch2008@126.com | |
Sponsors and Collaborators
LiNanlin,Ph.D, Chief Physician,Clinical Professor
Roche Pharma AG
More Information
No publications provided
| Responsible Party: | LiNanlin,Ph.D, Chief Physician,Clinical Professor, The department of Vascular endocrine surgery, Xijing Hospital |
| ClinicalTrials.gov Identifier: | NCT01652560 History of Changes |
| Other Study ID Numbers: | QTDS-01 |
| Study First Received: | July 21, 2012 |
| Last Updated: | July 25, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Xijing Hospital:
|
bevacizumab neoadjuvant chemotherapy HER2-negative breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013